Adaptive three-dimensional orthoses and methods for their manufacture and use

ABSTRACT

A conformable body interface is fabricated using a data set representing a three-dimensional, soft tissue body surface. The conformable body interface includes a body scaffold that is divided into two or more longitudinal segments separated by axial joints. Optionally, the body scaffold is further divided into two or more circumferentially split segments separated by circumferential joints. The axial joints are circumferentially constrained by elastic bands, tabs, or similar structures and the circumferential joints are longitudinally constrained by elastic axial tethers or similar structures. In this way, the body interfaces can accommodate swelling and bending of the body surface.

CROSS-REFERENCE TO RELATED APPLICATION

The present application is a divisional of U.S. patent application Ser.No. 15/730,201 (Attorney Docket No. 50016-704.301), filed Oct. 11, 2017,which is a continuation of PCT Application No. PCT/IB2016/000897(Attorney Docket No. 50016-704.601), filed Apr. 21, 2016, which claimsthe benefit of Provisional No. 62/151,920, filed on Apr. 23, 2015, theentire content of which are incorporated herein by reference.

BACKGROUND OF THE INVENTION 1. Field of the Invention

While orthotic intervention for physical rehabilitation has been knownfor centuries, splints, casts, and other orthoses still presentchallenges in implementation. Starting with temporary immobilizationusing splints made from sticks and casts made from plaster, the fieldhas progressed to fabricating dynamic orthoses from advanced composites.Recently, the field has progressed to the production ofthree-dimensional orthoses individualized for patient anatomies usingthree-dimensional scanning and printing techniques.

The primary functions of any cast or splint are to provide an externalstructure and to create physical conditions which promote healing withminimal complication. Traditional casts and splits often fail in atleast one of these functions.

Swelling (compartment pressure development) must be taken in toconsideration during casting of a splint. In standard procedures, themedical professional preparing a conventional hard-shell cast leavessignificant space for swelling of the injured anatomy. If made tootightly, the cast will restrict circulation, cause pain discomfort, andmay lead to compartment syndrome. If made too loosely, the will fail toprovide a stable environment for the healing process. Often, patientsare provided initially with a cast large enough to accommodate expectedswelling, and later with a relatively tighter cast to more closelyconform to the anatomy. The need to change cast or splints is of courseinconvenient.

Atrophy is another common problem associated with long-term cast usage.Atrophy is the wasting or loss of muscle tissue due to lack of physicalactivity caused by the splint's immobilization. Decreases in musclesize, strength and mobility are often observed. Loss in muscle size willoften prevent the splint from providing the support and stability neededto promote the healing process and may cause delayed union, non-unionand mal-union of the fracture.

Joint stiffness can be another problem associated with long-term splintor cast usage. Joint stiffness is the loss or reduction in range ofmotion in a joint caused resulting from long-term joint immobilization.Joint stiffness may be lessened or prevented by utilizing a dynamic oran adjustable passive orthotic product which allowing some joint motionduring the orthotic intervention.

External pressure may be applied to a fractured bone to promote healing.By applying external pressure during hardening, a cast or other orthosiswill often be able to apply a greater pressure on the bone during thesubsequent healing period. Such external pressure can reduce theoccurrence of complications such as delayed union, mal-union, andnon-union of the fracture.

For these reasons, it would be desirable to provide improved designs andmethods for fabricating splints, casts, and other orthoses. The designsshould allow for orthoses that can accommodate swelling after theorthosis has been fitted on a patient, should allow for a controlledapplication of pressure to the anatomy to promote bone growth duringhealing, should allow for individualizing an orthosis for specificpatients, and should achieve these objectives in an efficient and costeffective manner. At least some of these objectives will be achieved bythe inventions described hereinbelow.

2. Description of the Background Art

Casts, boots, and other shells which circumscribe a body limb or otheranatomy and which are axially spilt to allow for expansion and/orremoval are described in U.S. Patent Publication Nos. 2015/0272764;2015/0088046; 2014/0012171; 2013/0150762; and 2005/0171461; and U.S.Pat. Nos. 8,002,724; 5,776,088; 5,571,206; 7,981,068; 7,335,177;6,840,916; and 3,955,565. Other relevant background patents andpublications include U.S. Pat. Nos. 5,107,854; 5,823,975; 5,836,902;6,179,800; 6,725,118; 7,632,216; 8,613,716; and U.S. Publication Nos.2003/0032906; 2007/0132722; 2009/146142; 2011/0004074; 2011/0301520;2011/0302694; and European Patent No. 2671544.

BRIEF SUMMARY OF THE INVENTION

The present invention utilizes computer-aided design, softwareanalytics, digital manufacturing, sensing, digital data collection, andanalytical technologies to create a digital process for manufacturing,full-contact exo-skeletal orthoses with adaptable and/or adjustablestructural elements. Such orthoses are capable of providing acontrolled, medically beneficial interface with a patient body surfaceor other patient anatomy in order to reduce complications, promotebetter healing, and enhance protection of the anatomy being treated. Thepresent invention provides orthoses, such as splints and casts, havingbody scaffolds that are axially and/or radially split into a pluralityof segments or cells separated by joints that allow expansion inresponse to swelling. The segments or cells are assembled with elasticmechanical restraints that hold the segments and cells together andfurther apply external pressure when a covered body surface undergoesswelling. The present invention provides a swelling management system(SMS), a stiffness prevention system (SPS), methods for applyingexternal pressure through the orthotic and modular components. Inaddition to providing direct medical intervention through the structuraland modular components of the orthotic, the present invention canfurther provide locations for interfacing sensors with the body surface.The sensors in turn can provide data for real-time patient monitoringand for subsequent data mining.

The SMS introduces semi-dynamic self-aligning structure(s) andcomponents (mechanisms) to enable reducing or increasing thecross-sectional diameter and/or area of a body scaffold in response topost-trauma swelling followed by atrophy (decrease in the size ofmuscles), while maintaining the body scaffold's ability to provide afull contact hard shell orthosis.

SPS is a supplement to SMS to enable limited mobility on desired jointsin desired axis of motion (flexion, extension, abduction, adduction,pronation, and supination) through splint topology modifications and/orintroduction of additional mechanical components.

The invention also incorporates methods for applying external pressurethrough adjustable modular units positioned on a body scaffold andmethods for monitoring the applied pressure.

The invention also incorporates methods for delivering therapeuticstimulation through modular units positioned on a body scaffold.

Exemplary applications for the three-dimensional orthose of the presentinventions include upper-limb orthoses, lower-limb orthoses, spinal andneck orthoses, wrist orthoses, ankle orthoses, and similar applications.

The present invention relies on known three-dimensional printingtechniques for manufacturing personalized body scaffold. The methods maygenerally include three steps. First, known three-dimensional scanningor imaging technologies are used to directly or indirectly (from a mold)to generate a three-dimension data set representing a target bodysurface geometry. This three-dimensional data set will typicallyrepresent an interior geometry of the body scaffold being produced.Second, a physical structure for the custom three-dimensionally printedbody scaffold is determined and modeling. During the determining andmodeling step, specific design features of the body scaffold, such aslarge window openings or any three-dimensional modification applicableto body scaffolds or conventional orthotics can be marked on a patient'sskin with ink markers. A CAD designer can reference the markings andfollow them as instructions as the design file is being created. The CADdesigner may employ know design software and may follow any one or moreof a variety of design protocols, such as finite element analysis,generative design, parametric design, and virtual and augmented realitytechnologies. Third, three-dimensional printing or other digital ornumerically controlled fabrication methods produce the personalized bodyscaffold. The scaffolds may also be designed to incorporate othercapabilities including internet-of-things (TOT) devices and systems,signal processing units, wireless communication units (Bluetooth®,infrared, GSM, local wireless networks, and internet connectivity),on-board or remote interfaces (tactile, photometric, augmented orvirtual reality interface, web or software interface linked mobiledevices, smart phones, LED, LCD, tablets, laptops etc.), various typesof power sources (including thermoelectric generation, wireless energytransfer technologies, alternative and direct current), cloud computingand storage units.

Although the invention has been described as an adjustable, typicallyself-adjustable, body scaffold with a plurality of self-aligningsurfaces and elements for humans, in other embodiments is possible toadopt other products used by humans including, chairs, seats, saddles,athletic equipment, shoes, padding, helmets and partial or full bodyexoskeletal suits, etc. The embodiments of the invention can also beused for casts/braces for animals and custom saddles for horses andequestrians.

In a first aspect, the present invention provides a conformable bodyinterface which may be in the form of a splint, a cast, or otherstructure intended to at least partially surround and support someportion of the patient's anatomy, particularly including body limbs,body joints, a portion of the torso, and the like. Most commonly, theconformable body interface will be in the form of an orthotic intendedto support a body limb or body joint, typically after a fracture orother injury to the limb or joint.

The conformable body interfaces comprises a body scaffold, typicallyformed as a three-dimensional lattice, which has a longitudinal axiswhich will typically be aligned with a dimension of the patient'sanatomy, for example, being aligned with or along length of a bone inthe arm, leg, or body joint. The body scaffold is typically configuredto be removably placed over a conforming body surface, and the bodyscaffold will be divided into two or more longitudinal segmentsseparated by axial joints. The axial joints, in turn, are configured tocircumferentially separate which allows circumferential expansion of thescaffold in response to swelling of the body surface that often occursduring the healing process. The conformable body interface will usuallyfurther include a plurality of elastic constraints that span the axialjoints at axially spaced-apart locations along the body scaffold. Theconstraints are configured to elastically constrain radial expansion ofthe body scaffold so that the scaffold can accommodate swelling of thebody surface while maintaining a desired inward or supportive pressureagainst the body surface.

An exemplary embodiment, the body scaffold comprises a three-dimensionallattice which may be produced by three-dimensional printing or similardigitally controlled production techniques, such as stereo lithography(SLA), numerically controlled machining, and the like. The lattice willhave gaps, spaces, apertures, and the like, and such open structures aresuitable for a number of purposes, including placement of sensors forengagement against the body surface, such as described in co-pendinginternational patent application number PCT/IB 2015/002432, the fulldisclosure of which is incorporated herein by reference.

In further exemplary embodiments, the elastic constraints that span theaxial joints may comprise any one of a variety of structures which fullyor partially circumscribe the body scaffold. For example, the elasticconstraints may comprise elastic bands that fully circumscribe the bodyscaffold. Such elastic bands may be continuously elastic over theirlengths, often having a uniform elasticity at all points along theirlengths. Alternatively, the elastic bands may have discontinuouselasticity over their lengths. For example, the elastic bands may haveelastic portions separated by inelastic or non-distensible portions. Theelastic portions can be formed from elastic polymers, mechanicalsprings, or the like, while the inelastic portions could be formed fromnon-elastic polymers and other non-distensible structures and materials.

In alternative embodiments, the elastic constraints may comprise elastictabs having ends which are attached to the longitudinal segments andwhich do not fully circumscribe the body scaffold. Typically, such tabswill have one end attached to a first longitudinal segment and a secondend which is detachably or non-detachably attached to an adjacentlongitudinal segment. In other embodiments, such tabs may span more thantwo adjacent longitudinal segments while being detachably ornon-detachably secured to any two or more of those segments. When theelastic constraints comprise elastic tabs, the elastic tabs may becircumferentially aligned around the body scaffold so that they form agenerally continuous line of elasticity around that circumference.Alternatively, elastic tabs may be actually offset from each other atany pattern which is selected to provide specific elasticcharacteristics on the body scaffold at particular anatomical locations.By using elastic tabs which are detachably secured at least one end, thetabs may be detached in order to facilitate donning and removal of theconformable body interface over the body surface.

The elastic constraints will typically have fixed lengths, particularlywhen they're formed as a continuous band structure. Alternatively, insome cases, elastic bands may have adjustable lengths, e.g. allowing thebands to be cinched and/or loosened after placement over the bodyscaffold. Similarly, when tabs are employed as the elastic bands, thetabs may have fixed or adjustable lengths. In still further embodiments,the elastic constraints may provide other functionalities, for exampleincluding stress/strain transducers that allow measurement of forceresulting from radial expansion of the body scaffold, allowingmonitoring of body swelling during treatment.

In still further alternate embodiments, in addition to or instead of theplurality of discrete elastic constraints, one or more fully orpartially elastic covers, such as mesh or fabric sleeves, may be placedover the body scaffold to provide or contribute to the radially inwardforce on the body scaffold.

In exemplary embodiments, the actual joints comprise slip joints,typically comprising a male element along an edge of one longitudinalsegment and a female element along the edge of the adjacent longitudinalsegment. Such slip joints allow expansion and contraction of jointswhile maintaining alignment of the adjacent longitudinal segments. Insome cases, mechanisms can be provided for locking or adjusting theopening of the slip joints to prevent or control such lateraltranslation. Such locking mechanism may comprise various elements, suchas pins, pawls, gears, and the like. Pins may be used to lock the slipjoints by dropping them into holes aligned in the slip joints toimmobilize the joints at prescribed spaced-apart dimensions. Gears andpawls, in contrast, may be used to actively adjust and control thespacing between adjacent longitudinal segments.

Usually, the body scaffold is further divided into two or morecircumferentially split segments separated by circumferential joints.The circumferential joints are configured to axially separate inresponse to movement of the body surface, for example bending of a bodyjoint. The two or more circumferentially split segments are typicallyheld together by a plurality of elastic axial tethers, where the tetherstypically pass through axial channels formed in or through thecircumferentially split segments. The axial tethers will usually beanchored at one end at or near a distal circumferentially split segmentand at another end in a proximal circumferentially split segment. Thecircumferential joints are also typically slip joints that will allowpivoting between adjacent circumferentially split segments.

In a second aspect, the present invention provides methods forfabricating conformable body interfaces, such as those described above.Such fabrication methods comprise obtaining a data set representing athree-dimensional soft tissue body surface, which may be any of thetissue surfaces described above. A three-dimensional body scaffold isfabricated based on the data set so that the scaffold can be removablyplaced over the three-dimensional body surface to conform to at leastsome target regions on the surface. In particular, the data set definesa body scaffold that is divided into two or more longitudinal segmentshaving axial joints therebetween. The axial joints are configured toseparate in response to swelling of the body surface when the scaffoldis placed over the body surface, typically during healing of an injury.

In preferred aspects of the method, the data set further definesfeatures on the body scaffold configured to receive a plurality ofelastic constraints spanning the axial joints at axially spaced-apartlocation along the body scaffold. Such elastic constraints are able toelastically constrain radial expansion of the body scaffold in responseto swelling of the body surface. The data set typically further definestwo or more circumferentially split segments separated bycircumferential joints, which are configured to axially separate inresponse to movement of the body surface when the scaffold is placedover the body's surface during patient healing. In such cases, the dataset typically still further defines axial channels on the body scaffold.The channels are located and configured to receive a plurality ofelastic axial tethers spanning the circumferential joints atcircumferentially spaced-apart locations on the body scaffold toelastically constraining bending of the body scaffold. These fabricationmethods are typically performed using known three-dimensional printingand fabrication methods, such as three-dimension printing, stereolithography (SLA), and the use of numerically controlled machines formachining the body components. After the discrete components of the bodyscaffold are fabricated, the body scaffold may be further fabricated byattaching elastic and/or non-elastic constraints to the features formedon the longitudinal segments and positioning axial tethers within theaxial channels that span the circumferential joints between adjacentcircumferential segments.

BRIEF DESCRIPTION OF THE DRAWINGS

The novel features of the invention are set forth with particularity inthe appended claims. A better understanding of the features andadvantages of the present invention will be obtained by reference to thefollowing detailed description that sets forth illustrative embodiments,in which the principles of the invention are utilized, and theaccompanying drawings of which:

FIG. 1 is an embodiment of an adaptive splint with four longitudinallysplit segments and three circumferentially split segments, comprising ofa total of twelve individual body scaffold cells held together withthree elastic radial restraints and four axial tethers.

FIG. 2 is a circumferential portion of a personalized splint or otherbody scaffold with four longitudinally split segments.

FIG. 3 is a transverse cross-section of the splint of FIG. 2 shownwithout radial expansion.

FIG. 4 is similar to FIG. 3 shown with radial expansion.

FIG. 5 is a transverse cross-section of a radial slip joint in a closedconfiguration.

FIG. 6 is similar to FIG. 5 shown with the radial slip joint partiallyopened.

FIG. 7 is similar to FIG. 5 shown with the radial slip joint opened to alimit of circumferential expansion.

FIGS. 8-10 illustrate alternative radial slip joint configurations withstop elements that limit circumferential expansion.

FIGS. 11-13 illustrate the radial slip joints of FIGS. 3-5 a lockingmechanism having a locking pin for selectively preventing expansion andcontraction of the joint at different degrees of opening.

FIGS. 14-17 radial slip joints similar to those of FIGS. 3-5 havingadjustable locking mechanisms with ratchet mechanisms andrack-and-pinion mechanism, for providing a plurality of negative lockedstates.

FIG. 18 is a personalized splint with circumferentially split segmentsheld together by an axial tether.

FIG. 19 is an axial cross-section of the splint of FIG. 18 showingplacement of the tether.

FIG. 20 is an axial cross-section of the splint of FIG. 18 withillustrations of internal dynamics of the system.

FIGS. 21-23 are axial cross-sections of a circumferential V-type slipjoint.

FIGS. 24-26 are axial cross-sections of a circumferential C-type slipjoint.

FIG. 27 illustrates an upper circumferential portion of a body scaffoldwith SMS.

FIGS. 28-30 show the body scaffold of FIG. 27 in different degrees ofbending.

FIG. 31 illustrates a half body scaffold with SPS with a plurality ofaxial tethers and a ball joint serving as a circumferential slip joint.

FIG. 32 is an axial cross-section of the half body scaffold of FIG. 31

FIG. 33 illustrates two adjustable modular pressure units placed withina circumferential portion of a body scaffold with SMS.

FIG. 34 is a transverse cross-section of an adjustable modular pressureunit attached to a circumferential portion of a body scaffold with SMS.

FIG. 35 is a blowup representation of an adjustable modular pressureunit with a pressure sensor.

FIG. 36 is a blowup representation of an adjustable modular pressureunit with massage therapy components.

FIG. 37 is a blowup representation of an adjustable modular pressureunit with massage therapy components.

FIG. 38 is a body scaffold with a modular therapeutic unit and acircumferential sensor.

FIG. 39 is the section of a modular therapeutic unit attached to aportion of a body scaffold.

FIG. 40 is a blowup representation of a modular therapeutic unit

FIG. 41 is the cross-section of a circumferential sensor attached to aportion of a three-dimensional printed body scaffold with SMS.

FIG. 42 is an axial cross-section of the circumferential slip joint ofsplint of FIG. 29 illustrating the minimal tangential relationshipbetween two circumferential portions.

FIG. 43 is an axial cross-section of the circumferential slip joint ofsplint of FIG. 30 illustrating the sliding rail topology between twocircumferential portions

DETAILED DESCRIPTION OF THE INVENTION

The present invention provides a custom designed full contactexo-skeletal cast/splint with a plurality of adjustable and/orself-adjusting structural components closely fitted to a portion ofhuman anatomy. The structural solutions of the invention are developedin order to promote a controlled and medically beneficial relationshipbetween the orthotic and the patient. Although the structural solutionsof the invention are particularly suitable for post-fractureapplications, the methods and techniques described herein may also beused to treat other musculoskeletal and neuromuscular conditionsrequiring periods of orthotic intervention. The apparatus and methods ofthe present invention address a series of very commonly observedcomplications in post fracture management.

A Swelling Management System (SMS) introduces circumferential adjustmentcapabilities (increase or decrease) to personalized body scaffolds inorder to accommodate swelling and atrophy during an immobilizationperiod. SMS is implemented through dividing a portion (or portions) of abody scaffold along longitudinal lines into a plurality of segments(two, three, four or more) in order to create the basis for asemi-dynamic structure. The axially divided segments (referred to as“longitudinal segments”) interface at “circumferential joints” betweenneighboring longitudinal segments. An “elastic constraint”circumferentially restrains the separable longitudinal segments,typically an elastic band or other component or positioned around of insome cases embedded in the segmented body scaffold. An exemplary bodyscaffold structure is illustrated in FIGS. 1-4 with four longitudinalsegments 301 corresponding to a circumferential portion 101 of an upperextremity splint. FIGS. 3 and 4 show cross-sections taken throughsection 201 of FIG. 2.

A plurality of longitudinal segments 301 (also referred to as cells)together form a circumferential structure is illustrated in FIG. 3. Thelongitudinal segments 301 are joined by axial slip joints 302 that arelocated along the axial edges of each adjacent segment 301. The axialslip joints 302 allow the body scaffold to circumferentially expand overexpansion paths 304 and also provide a physical limit forcircumferential contraction. When fully contracted, the slip joints willbe in a “negative locked state.” When the axial slip joints are in anegative locked state, as illustrated in FIG. 3 (also in FIG. 5), thescaffold will protect the patient anatomy 102 from pressure and impact.The individual longitudinal segments 301 of the circumferentialstructure of the body scaffold are held together by one or more radialelastic constraining elements 303 that apply a radially inwardconstraining force on the longitudinal segments 301. The elasticconstraint 303, may take the form of an O-ring or other structures withsimilar elastic properties (springs, etc.). Rather than using a singleelastic restraining element, the same effect can be achieved using aplurality of elastic restraining and/or using non-circular elasticrestraining elements such as elastic restraining element 303 in FIG. 27.FIG. 4 illustrates physical forces observed in section 201 in an eventof circumferential expansion (an unlocked state) of axial slip joints302, being relatively spaced-apart from each other. Arrows 305illustrates the inward force generated by the elastic restrainingstructure 303. Arrows 306 illustrates the radially outward forcegenerated by patient anatomy. As shown in FIG. 4 individual longitudinalsegments 301 move circumferentially away from each other to accommodateswelling or other expansion of a patient anatomy. The axial slip joints302 allow the necessary circumferential expansion following paths 304between the cells. In this particular illustration, the dynamicstructure (SMS) is in a state of equilibrium with patient anatomyproviding an outward force that is balance by the inward force(s) of theelastic constraints 302. In FIG. 3, the system is in a negative lockedstate where the scaffold protects the anatomy from external pressure orimpact.

The axial slip joints 302 can be configured to allow circumferentialexpansion and/or contraction of the body scaffold in response toswelling and/or atrophy that often occurs during the healing process.The dynamics of the system are illustrated in greater detail in FIGS. 5,6 and 7 with focus to male edge 307 and female edge 308 of adjacentlongitudinal segments (cells) 301 on their motion paths 304.

As shown in FIGS. 5, 6 and 7, the axial slip joints 302 can beconfigured to allow dynamic circumferential expansion of a portion (orportions) of a body scaffold in response to developing edema. The bodyscaffold is initially applied to the patient anatomy with the slipjoints in their negative locked states as shown in FIG. 5. As edemadevelops, the male edge 307 and female edge 308 separate along path 304,as shown in FIG. 6. FIG. 7 represents the structural limit ofcircumferential expansion. This limit, of course, can be extended bylengthening the male and female edge components. Circumferentialexpansion occurs only so long as the radially outward pressure generatedby the patient anatomy 102 is greater than the radially inward pressuregenerated by the radial elastic restraining structure 303.

The axial slip joints 302 can also be configured to allow dynamiccircumferential contraction of a portion (or portions) of a bodyscaffold in order to provide and maintain close contact and support tothe patient anatomy during atrophy. The body scaffold is initiallyapplied to the patient anatomy with the slip joint in their expandedstates, as shown in FIG. 6 or 7. As the anatomy atrophies, the male and307 and female edge 308 come together along path 304, being limited onlyby the negative locked state of FIG. 5. Circumferential contractionoccurs only so long as the radially inward pressure generated by theradial elastic restraining structure 303 is greater than the radiallyoutward pressure generated by the patient anatomy 102.

In another embodiment, the axial slip joints 302 can be configured toallow dynamic circumferential expansion and contraction of a portion (orportions) of a body scaffold in order to cope with developing edemafallowed by atrophy. For this particular application circumferentiallyapart axial slip joint topology is applied to the patient as illustratedin FIG. 6. As edema develops, components 307 and 308 re-arrange theirpositions with respect to motion path 304. FIG. 7 is a representation ofre-arranged longitudinal segments with respect to increased muscle size,later on as edema disappear and give way to atrophy components 307 and308 rearrange their position as represented in FIG. 5 in to a lockedstructural state.

In another embodiment, alternative axial slip joint topologies, withrelatively more complicated designs, are offering a positive lockedstate to SMS. A positive locked state, meaning having an additionalphysical limitation for circumferential expansion are illustrated inFIGS. 8, 9 and 10. Similar solutions corresponding one male end 307 anda fitting female end 308 of adjacent longitudinal segments with relatedmotion paths 304 and the patient anatomy 102 are illustrated. In itsessence, any topology providing any path (circular, non-circular,twisting, rotational, linear, nonlinear, 3 dimensional) of motionbetween two or more adjacent segments with physical restraints isconvenient for having a controlled and medically beneficial physicalrelationship with patient anatomy.

Circumferential pressure 305 is generated from radial elasticconstraining element(s) 303 may either turn out to be beneficial orunbeneficial to the patient, depending on the nature and the state ofthe injury. Although SMS described above, create functioning structureswith circumferential adjustment capabilities (increase or decrease), anypressure or impact can reach patient anatomy unless the system is in anegative locked state. FIGS. 11-17 demonstrate methods for locking oradjusting the opening of the slip joints to prevent or control suchlateral translation. Additional locking mechanisms may need to beapplied from one or more designated locations between male 307 andfemale 308 components of axial slip joints. For practical reasons(accessibility and ease of use), it may be beneficial but not essentialto avoid radial elastic constraint element(s) 303. In a typicalembodiment as illustrated in FIG. 2, convenient locations for adoptingadditional locking mechanisms are marked with sections 202 and 203.

In one embodiment, an improved locking mechanism has locked and/orunlocked states, as illustrated in FIGS. 11-13. An exemplary lockingmechanism comprises pin(s) 401 or similar restraining elements andfitting holes 402 aligned in axial slip joints. Pins 401 are used toblock and adjust motion potential between segments by insertion orremoval 403 into holes at prescribed spaced-apart locations. FIGS. 11and 12 illustrate a method to create a completely fixed state betweentwo adjacent segments. Self-arrangement potential between two individualcells for both circumferential increase and decrease can be temporarilydisabled by fixing male 307 and female 308 cells by inserting a pin orsimilar restraining structures 401 through both of the elements. Forthis particular application suitable fitting hole geometries 402 must bepresented on both male and female cells. A number of hole geometries canalso be adapted to increase control over the fixed state between twocells. FIG. 13 illustrates a method to determine multiple positions tonegative locked state and still allow circumferential increase. Ingreater detail, a geometric position of negative locked state betweentwo individual cells can be arranged by inserting a pin or similarrestraining structures 401 through female 308 element of a radial slipjoint 302 and physically limit circumferential decrease and thereforethe negative locked state of the system. Multiple hole geometries onfemale cells located on motion path can be adapted as well as slidingpins embedded in to slots in order to increase control over the negativelocked state.

In another embodiment, an improved locking mechanism with multiplenegative locked states is illustrated in FIGS. 14 and 15. Theimprovement involve the adaptation of a linear ratchet mechanism inorder to allow continuous one directional special adjustment(circumferential increase for this case) between two adjacentlongitudinal sections. In greater detail, the ability to provide aplurality of negative locked states between two segments is achieved byadapting/embedding a linear ratchet mechanism in to axial slip joints.The mechanism comprises of three main parts, a linear rack 404, a pawl405 and a tension element 406 (spring). A linear rack 404 with a line ofuniform but asymmetrical tooth, having a moderate slope on one edge andmuch steeper slope on the other edge, is illustrated (FIGS. 14 and 15).When the teeth are moving in the unrestricted direction (circumferentialexpansion for this particular case) the pawl 405, easily slides up overthe gently sloped edges of the teeth. The spring 406 constantly forcesthe pawl 405 into depression between the teeth 404. When the teeth movein the opposite direction, however, the pawl will catch against thesteeply sloped edge of the first tooth it encounters, thereby locking itagainst the tooth and preventing any further motion in that direction.FIG. 15, illustrate the mechanism in an unlocked state caused bypresence of external pressure 407, applied to counter the push force ofthe spring 406, eventually lifting the pawl and unlocking the mechanism.Alternatively, a similar spring loaded with mechanism without thesliding teeth but with regular homogenous locking teeth could be easilyadapted.

In another embodiment, an improved locking mechanism with multiplecompletely locked states is illustrated in FIGS. 16 and 17. Theimprovement involve the adaptation of a rack and pinion type of actuatorto allow a number of locked states for circumferential adjustment(increase or decrease). In greater detail, the ability to enable/controlcircumferential expansion and contraction with a number of completelylocked states between two segments is achieved by adapting/embedding arack and pinion type of actuator in to axial slip joints. The mechanismcomprises of three main parts, a linear gear called the rack 408, acircular gear called the pinion 409 and a break system 410. A linearrack 408 with a line of uniform symmetrical tooth is aligned with acircular gear 409 located on the adjacent segment of an axial slipjoint. The rotational motion applied to the pinion causes the rack tomove relative to the pinion, thereby translating the rotational motionof the pinion into linear motion or the opposite. A sliding lockmechanism 410 is also introduced to lock or unlock the system. FIG. 16illustrates the system in a locked state with the sliding 411 lock 410blocking circular motion of the pinion 409 and eventually blockingcircumferential adjustment of the rack 408. FIG. 17 illustrates thesystem in an unlocked state with a sliding lock 410 not interfering withthe circular motion of the pinion 409 and thus circumferentialadjustment of the rack 408. Alternatively, a circular ratchet mechanismwith a circular rack with asymmetrical tooth, a pawl and a tensionspring could easily be adapted to allow circumferential increase whilebeing in a negative locked state.

Post-fracture edema accumulation, followed by atrophy are unescapabledynamics in fracture management. Effects of edema accumulation andatrophy are most intense in areas where muscle density is highest,typically resulting in uneven swelling or shrinkage within the bodyscaffold . The overall circumferential adjustment capabilities andmedical performance of a portion or portions of longitudinal segmentswill significantly improve by further dividing the body scaffold intransverse axis into a plurality of longitudinal sections (two, three,four or more) making each subjected cell being part of a radial(circumferential) and axial (longitudinal) portion simultaneously. Thecomponents of a longitudinal portion are held together throughstructural modifications of cells and introduction of at least one axialtether mechanism with sufficient compressive force, pushing cellstowards each other. The longitudinal portion 103 (FIGS. 1 and 18) of anupper extremity splint covering a section of human anatomy 102 is atypical embodiment of SMS with a plurality of circumferentially splitsegments. Section 204 (FIG. 18) is illustrated in FIG. 19 to providegreater detail regarding to the structure and dynamics of the system.

FIG. 19 illustrates a longitudinal section with three circumferentiallysplit segments. These three cells comprise a longitudinal portion(structure) which has three circumferential slip joints 501 locatedbetween adjacent cells. Male or female slip joint topology may exist oneach end of each circumferentially split segments. Circumferential slipjoints 501, align each individual cell 301 in their longitudinal axis.The structure is held together with the support of at least oneadditional axial constraining mechanism, constantly pulling cellstowards each other. The axial constraining mechanism consists of twoelements. A first element comprises a string or wire-like tether 502which passes through or on the surface of cells and connect each elementin a longitudinal axis. This wire-like constraint 502 is also observablein FIG. 3. The wire like constraint may take the form of a wire, a line,a string with flexible, inflexible or partly flexible materialcharacteristics. A plurality of anchoring elements 503 or points fix thewire-like axial tether and cells together. Rather than passing throughthe cells with one single element, a plurality of cells corresponding alongitudinal structure can be linked through a series of wires andanchors reaching the same effect for subdivided structures. Theanchoring elements 503 are located in proximal and distal end of thebody scaffold and may take the form of designated design solution(s)within the cells or embodied as external elements with screws or gearsfor tension adjustment capabilities.

FIG. 20 illustrate the physical forces and self-alignment capabilitiesobserved in the same section (section 204 and FIG. 19). The compressiveforce 504 generated by the axial constraint mechanism (axial tethers),combined with circumferential slip joints 501 hold the longitudinalstructure 103 intact. Furthermore, the circumferentially inward forcegenerated by a radial elastic restraining element (illustrated in FIG. 3as 305) is also illustrated in this figure as a single horizontal forcepushing each cell towards patent anatomy (102). The radially outwardforce generated by the patient anatomy or the locked state of axial slipjoints, (illustrated in FIG. 3 as 306) is also illustrated in thisfigure as a series of horizontal forces pushing each cell on theopposite direction. In the case of an edema accumulation or atrophy orany significant change in the patient anatomy, each circumferentiallydivided cell of the longitudinal group has the capacity to rearrange itsposition according to the modified patient anatomy and adjacent cells.As a longitudinal structure with a plurality circumferentially dividedcells, circumferential slip joints and an axial tether, the dynamics ofthe system resemble a folding white cane typically used by the visuallyimpaired. 505 illustrates rotational paths for self-alignment of eachindividual cell in a longitudinal group. The range of motion (rotationalcapability) of each cell can be regulated by modifying circumferentialslip joint topology 501.

In an embodiment, alternative circumferential slip joint topologies canregulate range of motion of a cell in its axis, implementations ofdifferent design solutions are disclosed over section 204 in FIGS. 21,22, 23, 24, 25 and 26. The improvement involve different male and femalecircumferential slip joint topologies (501) for regulating (limiting)the dynamics of a longitudinal group. Male end of an individual cell ina longitudinal group (103) is illustrated with 506. Female end of anindividual cell in a longitudinal group (103) is illustrated with 507.

FIGS. 21-23 illustrate a “V” type (like) circumferential slip jointtopology 501 between male 506 and female 507 ends of twocircumferentially split adjacent segments. The “V” type circumferentialslip joint topology is very convenient for limiting (regulating) therange of motion 505 between adjacent segments. FIG. 21 illustrates avery limited range of motion 505 due to very limited space between male506 and female 507 adjacent segments. FIG. 22 illustrates an increasedrange of motion 505 due to an increased space between male 506 andfemale 507 adjacent segments. FIG. 23 illustrates an asymmetrical rangeof motion which is limited in one direction and extended in the oppositedirection due to asymmetrical space between male 506 and female 507adjacent segments.

FIGS. 24-26 illustrate a “C” type (like) circumferential slip jointtopology 501 between male 506 and female 507 ends of twocircumferentially split adjacent segments. The “C” type longitudinalslip joint topology is very convenient for very large the range ofmotion 505 between two adjacent segments. FIG. 24 illustrates a largerrange of motion 505 due to sliding space between male 506 and female 507adjacent segments. Alternatively, the structure can evolve into a balland socket type joint 510 as discussed in FIGS. 31 and 32. FIG. 25illustrates an extremely increased range of motion 505 due to use of two“C” type male 506 adjacent segments. FIG. 26 illustrates an asymmetricalrange of motion which is limited in one direction and extended in theopposite direction due to asymmetrical space between 506 and female 507adjacent segments. Similar circumferential slip joint topology canregulate range of motion between adjacent cells with ease.

A stiffness prevention system (SPS) can be introduced as a supplementarymethod for SMS to enable and/or regulate anatomic motion in joints underorthotic intervention. SPS is implemented through first structuralmodifications to circumferential slip joints in order to physicallyallow such desired motion. Second, precise positioning of the elementsaround anatomic joints allows such a desired anatomic motion. Finally,the axial tether mechanisms may be adjusted in order to regulate suchmotion. Desired anatomic motions include flexion, extension, abduction,adduction, pronation, and supination. SPS is explained between twocircumferential portions of an upper extremity splint 101 and 104covering a wrist, is a typical embodiment of SPS. Section 205 (FIG. 27)is illustrated in FIGS. 28, 29 and 30 to provide greater detailregarding the structure and dynamics of the system.

FIG. 28 illustrates an embodiment of SMS without any structuralmodifications to circumferential slip joints 501 in order to incorporateSPS and can be referred as the default structural state of the system.In order to provide a stable and durable structure, circumferential slipjoints 501 are flat and in full contact with each other.

In an embodiment, illustrated in FIG. 29, two circumferentially splitsegments 101, 104 of a body scaffold are configured to axially separatein order to regulate anatomic motion 508 (such as bending of a joint).The fitting full contact relationship between the two components of acircumferential slip joint 506, 507 is modified to allow pivotingbetween the segments. Section 210 is illustrated in FIG. 42 to providegreater detail regarding the structure of slip joints 501. It isadvantageous that a minimal tangential contact area 513 be maintainedbetween the two circumferential portions over a body joint to physicallyallow the desired anatomic motion. Anchor points 503 (FIG. 29) play akey role in regulating anatomic motion since increasing or decreasingtension 509 of axial tethers 502 will inevitably rearrange the positionand the angle between the segments of the body scaffold.

In an embodiment, as illustrated in FIG. 30, two circumferentially splitsegments 101, 104 of a body scaffold are configured to axially separatein order to regulate anatomic motion 508 (such as bending of a joint).The fitting full contact relationship between the two components of acircumferential slip joint 506, 507 is modified to allow sliding betweenthe segments. Section 211 is illustrated in FIG. 43 to provide detailregarding the structure of slip joints with sliding rail type topologybetween male 506 and female 507 slip joints. It is essential that thesliding rails between the two circumferential portions, are placed overa body joint to physically allow the desired anatomic motion. Anchorpoints 503 (FIG. 30) play a key role in regulating anatomic motion sinceincreasing or decreasing tension 509 of axial tethers 502 willinevitably rearrange the position and the angle between thecircumferential portions of the body scaffold.

Alternatively SPS can also be introduced as an independent systemincorporating the related longitudinal alignment mechanism described inSMS in order to enable and regulate anatomic motion to desired joints ina half body scaffold. In an embodiment, a plurality of longitudinalrestraining mechanisms are implemented to regulate anatomic motion withthe use of at least one additional ball joint between portions of a halfsplint, are illustrated in FIGS. 31 and 32. FIG. 31 illustrates a halfsplint consisting of two cells (301), four longitudinal restrainingelements (502) attached to two adjustable anchoring elements each (503),a ball joint (510) as an embodiment of longitudinal self-aligning slipjoint topology (501) and a padding unit (309) to support patient anatomy(102).

The ball joint between two segments enable an extremely flexible rangeof motion between the elements and must be regulated with a plurality ofaxial tether mechanisms. For this particular embodiment, the axialtether mechanisms can be grouped in to two groups. The first two of theaxial tether mechanisms are intended to regulate ulnar and radialdeviation and are positioned on the sides (lateral and medial) of thebody scaffold, the dynamic effects of these two restraining elements aresimilar to the dynamics described in FIGS. 29 and 30. The second two ofthe axial tether mechanisms are intended to regulate flexion/extension511 and are positioned on the central axis of the body scaffold. Section206 is illustrated in FIG. 32 to provide greater detail regarding thestructure and the dynamics of the system. A ball joint 510 enablesmotion between two segments around the anatomic joint of the patient.Two axial tethers 502 are positioned at both sides of the ball joint toregulate desired motion 511. A tension of the axial tether mechanism maybe adjusted by cinching the anchor points 503 along the axis ofadjustment for each element is illustrated with 512.

Other motion regulating structures such us different kinds of joints andrails can be adapted between two portions for a variety of anatomicmotions. The essentials of the system are placement of slip joints, balljoints and slots within the body scaffold to match the location ofanatomic joints and the use of axial restraining mechanisms described inSMS in order to regulate motion.

The invention also incorporates methods for applying external pressurethrough the orthotic. Typically, fractures require some level ofexternal pressure in order to support to the injured area. This pressurehelps stabilizing the area and also help the fracture to heal. Bones arepiezoelectric structures in nature, and the transfer of ions is animportant contributor to fracture healing. Conventionally, the externalpressure is applied by a medical professional during casting of thesplint and particularly during cast's solidification process. Thispressure can be applied to the fractured anatomic location by themedical professional in the same manner. Due to the nature ofconventional applications there is also no way of measuring pressure orprecisely defining the area for applying the pressure to the relevantareas.

In an embodiment external pressure to patient anatomy can be appliedthrough modular and adjustable pressure units. FIG. 33 illustrates twomodular and adjustable pressure units attachable to a portion of a bodyscaffold with or without SMS. The body of modular and adjustablepressure unit 601 maybe 3D printed or produced with conventionalmanufacturing technologies. The area delivering pressure to the patientanatomy 602 is formed from a soft rubber-like viscoelastic materialand/or may be produced from layers of different materials with differentmechanical and chemical properties. The knob 603 is for adjusting thepressure delivered to patient anatomy. The modular unit can be fixed tothe body scaffold through screws 604 and/similar mechanical solutionssuch as magnets. FIG. 34 is a sectional view that provides more detailsregarding to the structure and the dynamics of the system. The screwtype shaft 605 connects the knob 603 the main body of the pressure unit601 eventually regulating the position of the interface element 602. Thephysical relationship between the interface element 602 and the patientanatomy 102 is illustrated with 606. Alternatively, the knob, shaft andinterface element combination can be embedded inside the body scaffoldfor the same external pressure adjustment purposes.

In another embodiment, a pressure sensor is used to monitor the physicalrelationship between the modular adjustable pressure unit and thepatient anatomy is illustrated in FIG. 35. The data mining feature isachieved by positioning (or embedding) a pressure sensor 607 between thelayers of the interface element 602. The data mined by the sensor istransferred through a wire 608 connecting the sensor to a IOT device 609with relevant computational and connectivity capabilities (an IntelEdison or Curie is a good example of such a device). The power source ofthe system is illustrated with 610 that may be a battery or a receiverfor wireless energy transfer system. Alternatively, the knob, shaft,interface element and sensor combination can be embedded inside the bodyscaffold for the same external pressure monitoring purposes.

In another embodiment heat and cold to patient anatomy can betransferred trough modular pressure units is illustrated in FIG. 35.Heat can be generated using electrical resistors, thermoelectricgenerators, and the like. Thermotherapy (heat therapy) and cryotherapy(cold therapy) may be achieved by positioning (or embedding) athermoelectric generator 607 between the layers of the interface element602 for this particular application the section of the interface elementin contact with patient anatomy must be from a highly thermo-conductivematerial also the section of the interface element in contact with theshaft 605 must be from a thermos-insulated material. The energy requiredfor the application and controlling signal is transferred through a wire608 connecting the thermoelectric generator to an IOT device 609 withrelevant computational and connectivity capabilities (Intel Edison orCurie is a good example of such a device). The power source of thesystem is illustrated with 610 which may be a battery or a receiver forwireless energy transfer system (or similar power sources).

Rehabilitating any injury can be a time consuming and frustratingprocess. While the purpose of physical rehabilitation is to increasestrength and flexibility, it usually ends prematurely before an injuredarea has been restored to its full pre-injury state. Massage plays animportant role as a supplement to standard injury rehabilitationprocedures. By encouraging circulatory movement and relaxing muscles,massage helps the body pump more oxygen and nutrients into tissues andvital organs. This allows the rehabilitating injured area(s) to becomemore flexible and heal at an accelerated rate.

In an embodiment massage therapy could be applied to patient anatomytrough modular units. FIGS. 36 and 37 illustrates modular units withembedded electrical motors, mechanical parts and massage interfaces fordelivering two kinds of massage therapy. FIG. 36 illustrates a blowupillustration of a modular unit with circulatory type of massage. Theelectrical engine 611 is positioned along a central axis of the unit andconnects to a reduction gear 612 which reduces the rpm to increase thetorque of the system. Rotational motion is transferred through the mainbody of the modular unit 601 via a shaft 605 to the massaging element613, and the circular motion of the system is illustrated at 614. Thesystem is fixed to a body scaffold via screws 604 (or other convenientmechanical solutions) and may be controlled by an IOT device 609 and/ordirectly connected to a power source 610. FIG. 37 illustrates a detailedillustration of a modular unit with punch type of massage. Theelectrical engine 611 is positioned perpendicular to the central axis ofthe unit connects to a Scotch yoke type of gear 615 which convertscircular motion of the engine into a linear piston like up and downmotion. Later linear motion is transferred trough the main body of themodular unit 601 via a shaft 605 to the massaging element 613 the up anddown motion of the system is illustrated with 617. The system is fixedto a body scaffold via screws or similar mechanical solutions 604 andmay be controlled by an IOT device 609 or directly connected to a powersource 610. Other types of similar massage applications or techniquescould be adapted using the similar methods and structures.

In additional aspects, the present invention provides a method forfabricating a comfortable body interface as a hub for therapeuticequipment. In some embodiments, the conformable interface element mayfurther include a therapeutic element, a mechanism for pushing thetherapeutic element towards the patient anatomy and an externalelectrical power source is illustrated in FIGS. 38, 39 and 40. A modularunit with the capacity to stabilize certain medically beneficial therapydelivering probes (effectors) to enable their usage during periods oforthotic intervention, a therapy delivering modular unit 601 in FIG. 38.The cross-section of the modular is unit 208 and is illustrated in FIG.39 and the blowup representation of the same unit is illustrated in FIG.40. Medically beneficial therapy delivering probe 618, is held by astabilizer ring. This stabilizer ring 619, is pushed towards the patientanatomy 102 with the support of a spring (or an object with similarsuspension qualities) 620. The mechanism comprises the therapydelivering probe (effector) and a stabilizer ring, and the spring isheld together between the back lid 621 and the main body 601 of themodular unit. Arrow 622 illustrates the direction of contact with thepatient anatomy. Sufficient contact between the therapy-delivering probeand the patient anatomy is crucial for delivering the therapeuticenergy, and the spring acts as a buffer between the elements toaccommodate edema development or other changes in the anatomy. A cable623 connects the medically beneficial therapy delivering probe to apower source 624. Exemplary therapeutic applications delivered throughprobes and skin contact include LIPUS (low pulsed ultrasoundstimulation), TENS (transcutaneous electrical nerve stimulation), EMS(electrical muscle stimulation), FES (functional electricalstimulation), NMERS (neuromuscular electrical stimulation), IFC(interferential current), High Voltage Stimulation, Iontophoresis etc.

In additional aspects, the present invention provides a method forfabricating a comfortable body interface as a hub for sensorytechnologies. In an embodiment structural dynamics of SMS is adapted tomonitor circumferential changes in a cross-sectional portion.

A circumferential monitoring unit with a strain gauge, an electroconductive O-ring, a temperature sensor and relevant electroniccomponents 701 is illustrated in FIG. 38. The cross-section 209 of thesensory unit is illustrated in FIG. 41. The adaptive orthotic structureis held to gather by pressure applied by the electrically conductiverubber O-ring 303. In the event of circumferential increase or decrease,the electrically conductive rubber O-ring will stretch or contract inresponse. A strain gauge sensor 702 can measure changes inelectro-conductivity of the rubber O-ring due to stretching orcontracting. Alternatively, the same system can be implemented to axialtethers. The sensory capabilities of the unit is also expanded with anadditional temperature sensor 704, for monitoring the local bodytemperature of the patient, this data is also important since edemaaccumulation presents itself with an increased body temperature. Thesystem also incorporates a microcomputer with relevant capabilities 705,batteries 706 or a receiver for wireless energy transfer system, andwiring. FIG. 42 is a cross-sectional view of the circumferential slipjoint of splint of FIG. 29 illustrating the minimal tangentialrelationship between two circumferential portions. FIG. 43 is across-section of the circumferential slip joint of splint of FIG. 30illustrating the sliding rail topology between two circumferentialportions.

What is claimed is:
 1. A method for fabricating a conformable bodyinterface, said method comprising: obtaining a data set representing athree-dimensional, soft tissue body surface; and fabricating athree-dimensional body scaffold which can be removably placed over thethree-dimensional body surface to conform to at least some targetregions of said surface; wherein the data set defines a body scaffoldwhich is divided into two or more longitudinal segments having axialjoints therebetween and wherein said axial joints are configured toseparate in response to swelling of the body surface when the scaffoldis placed over the body surface.
 2. A method as in claim 1, wherein thedata set further defines features on the body scaffold, which featuresare configured to receive a plurality of elastic constraints spanningthe axial joints at axially spaced-apart locations along the bodyscaffold to elastically constrain radial expansion of the body scaffoldin response to swelling of the body surface.
 3. A method as in claim 2,wherein the data set further defines two or more circumferentially splitsegments separated by circumferential joints which are configured toaxially separate in response to movement of the body surface when thescaffold is placed over the body surface.
 4. A method as in claim 3,wherein the data set further defines axial channels on the bodyscaffold, which channels are configured to receive a plurality ofelastic axial tethers spanning the circumferential joints atcircumferentially spaced-apart locations on the body scaffold toelastically constrain bending of the body scaffold.
 5. A method as inclaim 4, further comprising attaching elastic constraints to thefeatures spanning the axial joints and positioning axial tethers withinthe axial channels spanning the circumferential joints.